Quality Engineer

Quality Engineer

Location:

Los Gatos, CA

Job type:
Fulltime

Technical/Functional Skills

· Quality engineering working knowledge and quality management experience

· Working knowledge of ISO, MDD, FDA QSR 21 CFR 820 / ISO 13485 quality system requirements and the ability to provide expert knowledge of both regulatory requirements and other compliance areas to minimize risk across product lines

· Strong working knowledge of ISO 14971 risk management process (system risk analysis, DFMEA/FMEA and other risk management tools)

· Extensive design/sustaining quality experience within medical device industry

· New product development and post launch support activities, product remediation and risk management activities

· Working knowledge of Microsoft office products (MS Word, Excel) and statistical analysis software tools

· Writing protocol and reports for design and product validation, and execution

· Engineering change order

· Development of a standard procedure (SP), related work instructions (WI), forms, checklists for design verification and validation activities

Roles & Responsibilities

· Ensure robust technology transfer to products from the development stage to post launch/operations

· Support the development of product, process and packaging requirements that are complete, compliant and effective

· Ensure product, systems and processes are current in relation to global regulatory requirements

· Work with core teams and development partners to ensure robust design quality practices are embedded and applied

· Work with quality engineers and project teams to ensure the continued application of risk management principles in the post-launch environment

· Partner with reliability engineering to ensure that robust design reliability practices are embedded and applied

· Define the controls and quality standards for new products and design changes

· Identify opportunities to continuously improve quality, cost and time factors, consistent with business objectives

· Provide constructive technical challenge to R&D and other technical functions to drive better team performance and project outcomes

· Support organizational development and improvement of the quality system

Education

· Mechanical/Electro mechanical/Electrical/Bio-medical engineering

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Preferred education:

Master's degree or Ph.D.